Kornimate/medical-research-clean huggingface dataset:
hip activation vs. hip activation + core stabilization

Conditions: Movement, Abnormal; Lower Extremity Problem

Summary: the purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (hep) versus a hip activation training hep alone on lower extremity (le) frontal plane mechanics in healthy individuals. specific aim 1: to determine whether between- and/or within-group differences exist on the forward step-down test (fsdt) when comparing a combined hip activation and core stabilization training hep as compared to a hip activation training hep. specific aim 2: to determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training hep to a hip activation training hep. specific aim 3: to determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (semg) when comparing a combined hip activation and core stabilization training hep to a hip activation training hep. specific aim 4: to determine whether a dose-response relationship exists between hep compliance and change on the fsdt, peak external knee abduction moment, and semg.


Eligibility criteria:
inclusion criteria: * participants will be current first- or second-year doctor of physical therapy (dpt) students in the school of allied health professions (sahp) at louisiana state university health shreveport over the age of 21. exclusion criteria: * current pain or pathology in either le which currently limits their ability to perform the fsdt or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (dra) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials.
outcome of endodontic treatment in patient treated with a hydraulic sealer

Conditions: Apical Periodontitis

Summary: the objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.


Eligibility criteria:
inclusion criteria: * a permanent, single or multi-rooted mature tooth * clinical diagnosis of irreversible pulpitis * diagnosis of apical periodontitis exclusion criteria: * subjects with immune-compromised status * subjects with an overall poor prognosis for their treatment

Keywords: root canal obturation hydraulic sealer single cone endodontic outcome
study of the effect of n-acetyl cysteine on the renal graft function biomarkers (il18, ngal)

Conditions: Disorder Related to Renal Transplantation

Summary: the purpose of this study is to investigate the effect of (nac) n-acetyl cysteine on biomarkers of delayed graft function (dgf), including neutrophil gelatinase associated lipocalin (ngal) and intereleukin 18 (il18).

kidney transplantation is the best treatment for most patients with end stage renal failure, but limited numbers of suitable kidneys are available for transplantation. so preservation of graft is vital. this necessitates the studies and interventions to improve outcome of renal transplantation surgery. delayed graft function (dgf) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. dgf is a consequence of ischemic and reperfusion injuries (iri), and oxygen free radicals have a main role in pathophysiology of dgf. in meta-analysis studies, it has been demonstrated that dgf has a correlation with long and short time graft survival. despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. major causes of this problem are the lack of appropriate markers for early diagnosis of dgf and on the other hand lack of appropriate and effective interventions to controll dgf. studies have shown that n-acetyl cysteine (nac) can induce gsh synthesis, scavenger of free radicals, and infusion of nac had similar effects as glutathione. this is a randomized clinical trial (rct) on patients who have received kidney transplantation from living donors. sixty transplanted patients will be randomized into 2 groups. the first group of patients will be treated with nac 600mg 6 hr before transplantation and two doses of nac 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. for all patients entered the study, urinary concentrations of il18 and ngal will be measured in designated times. risk factors of dgf will be compared in two groups and effectiveness of nac in reducing dgf will be determined.

Eligibility criteria:
inclusion criteria: * patient receiving transplantation from living donors exclusion criteria: * having a neoplastic disease * brain tumor * having inflammatory diseases in their active phase (sle) * an acute infection, meningitis, sepsis * sickle cell disease * pregnancy * cardio-renal syndrome * endogenous cushing's syndrome * chronic use of cimetidine * a history of acute pancreatitis in recent months * multiple sclerosis * cardiac bypass in a recent month * cirrhosis due to hepatitis c * having alzheimer's disease * having a untreated major depressive illness or schizophrenia * stroke in recent months * hyperoxaluria * sensitivity to sulfonamides

Keywords: kidney transplantation n-acetyl cysteine living donor delayed graft function
vaccine therapy in treating patients with stage iii or stage iv melanoma that cannot be removed by surgery

Conditions: Intraocular Melanoma; Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: this phase ii trial is studying how well vaccine therapy works in treating patients with stage iii or stage iv melanoma that cannot be removed by surgery.

objectives: * determine the antitumor immune response in patients with unresectable stage iii or iv melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (gm-csf), and montanide isa-51. outline: patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (gm-csf), and montanide isa-51 on days 1, 8, 15, 29, 36, and 43. patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. projected accrual: a maximum of 29 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of melanoma * unresectable stage iii or iv disease * mucosal or ocular disease allowed * positive hla-a1, -a2, or -a3 expression patient characteristics: age * 12 and over performance status * ecog 0-1 life expectancy * not specified hematopoietic * absolute neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * hemoglobin \> 9 g/dl hepatic * liver function tests ≤ 2.5 times upper limit of normal (uln) renal * creatinine ≤ 1.5 times uln cardiovascular * no new york heart association class iii or iv heart disease other * weight ≥ 100 pounds * not pregnant or nursing * no other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * no prior vaccination with any of the peptides used in this protocol * more than 1 year since prior melanoma vaccine therapy * more than 4 weeks since prior immunotherapy * more than 4 weeks since prior growth factors * more than 4 weeks since prior allergy shots chemotherapy * more than 4 weeks since prior chemotherapy endocrine therapy * more than 4 weeks since prior steroid therapy radiotherapy * more than 4 weeks since prior radiotherapy surgery * prior tumor resection allowed

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma recurrent intraocular melanoma iris melanoma extraocular extension melanoma ciliary body and choroid melanoma, medium/large size
nordic randomized trial on laparoscopic versus vaginal cerclage

Conditions: Preterm Birth; Cervical Insufficiency

Summary: every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. it is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. during pregnancy, this channel must remain closed until the beginning of term labor. a weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. to prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy. to evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the nordic countries and england

both vaginal and abdominal cerclages are procedures that have been used to prevent preterm birth for more than 50 years. however, only one previous study (mavric, shennan et al. 2020) has compared the two methods in a randomised trial. other than evidence from the mavric trial there is uncertainty whether an abdominal cerclage should be preferred over vaginal cerclage, and which women would benefit from it the most. noract is an open, multicenter, superiority, randomized controlled trial with the overall objective to compare laparoscopic versus vaginal cerclage in woman in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. participants will be recruited pre-pregnancy or in early pregnancy and randomised to vaginal or laparoscopic cerclage. if randomised to laparoscopic cerclage this will be inserted pre-pregnancy or before 10+0 weeks of gestation. the vaginal cerclage will be inserted during pregnancy, before 16+0 weeks of gestation. a total sample of 188 participants will be included to detect a target difference of 15% in the primary outcome between the two groups. the two primary outcomes are delivery before 32+0 weeks of gestation and baby death. the study extends from sites in denmark, sweden, norway, finland, iceland, and the united kingdom.

Eligibility criteria:
inclusion criteria: * women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. * not yet pregnant or \<10 weeks' pregnant. exclusion criteria: * any circumstance under which the clinician is not willing to randomize is an exclusion criterion. * any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks). * language difficulties.

Keywords: cerclage
assess the efficacy and safety of alefacept with narrow band ultraviolet b phototherapy (nbuvb) vs. alefacept alone in chronic plaque psoriasis subjects

Conditions: Plaque Psoriasis

Summary: assess the efficacy and safety of alefacept with nbuvb compared to alefacept alone in chronic plaque psoriasis subjects. combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on t cells


Eligibility criteria:
inclusion criteria: * subject has given written informed consent * subject has a diagnosis of moderate to severe chronic plaque psoriasis involving \>=10% with a psoriasis area and severity index (pasi) score \>=10 at baseline * subject has cd4+ t lymphocyte (cd4) count at or above the lower limit of normal * male and female subjects must use an adequate means of contraception from screening to end of study. exclusion criteria: * subject who received alefacept in the past * subject who has shown no improvement following an adequate course of nbuvb in the past * subject who has been treated in the past with either therapy or cyclosporine * subject with any active cancer, including skin cancer at baseline * subject with erythrodermic, pustular or predominantly guttate psoriasis * subject who has used treatment for psoriasis prior to baseline as follows: * topical treatment within 14 days * oral treatment within 28 days * broad band uvb (bbuvb) or nbuvb treatment within 56 days * biological treatment within 84 days * serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug * subject with a history of drug or alcohol abuse within the past 2 years * subject that is known to be infected with the aids virus * subject with any other skin disease or other disease that might interfere with psoriasis status assessments * female subject who is nursing, pregnant or planning to become pregnant while in this study * subject who is currently enrolled in any other investigational drug or device study

Keywords: plaque psoriasis alefacept amevive narrow band ultraviolet b phototherapy
a phase 1 study to evaluate safety and tolerability of nono-42 in healthy adults

Conditions: First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke

Summary: the purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending intravenous dose of nono-42 administered to healthy adults. participants will be administered a single intravenous dose of nono-42 or placebo. participants will be confined for 24 hours post dose with a follow-up visit at day 4 and day 28.

the trial was a single, adaptive dose, dose escalation study in healthy male and female adults. the trial was randomized, double-blind, placebo controlled and evaluated the safety, tolerability, and pk of iv nono-42 in healthy adults. each healthy volunteer was administered a single iv dose of study drug or placebo. it was planned that up to 10 dosing cohorts would be evaluated. a cohort may have been repeated or added if necessary. cohort 1 included 4 healthy volunteers (1:1 randomization of nono-42 to placebo) with a sentinel dose of 2 healthy volunteers (1:1). cohorts 2 to 10 were to include 10 new healthy volunteers dosed at each dose level (4:1 randomization of nono-42 to placebo) during the single dose escalation. sentinel dosing with 2 healthy volunteers (1:1) occurred at each dose escalation. both the dose concentration and the dosing duration may have been adjusted.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures, clinic visits, blood draws, and availability for the duration of the study * healthy adult male or female aged 18 to 60 years old. * body mass index (bmi) within 18.5 kg/m2 to 30.0 kg/m2, inclusively * body weight less than or equal to 120 kg * good bilateral venous access sufficient for iv infusions as judged by the investigator or designee * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ecg, as determined by an investigator exclusion criteria: * female who is lactating or pregnant * history of significant hypersensitivity to nono-42 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability * history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, renal, hepatic, or dermatologic disease * presence of clinically significant ecg abnormalities, or any qt interval abnormalities, at the screening visit, as defined by medical judgment * immunization with a covid-19 vaccine in the 14 days prior to the first study drug administration or plans for vaccination * blood pressure below 100 mmhg systolic and 60 mmhg diastolic, and any upper limit is deemed clinically significant by the investigator * estimated glomerular filtration rate (egfr) of \<60 ml/min.
observational non-interventional study (anwendungsbeobachtung) with aptivus® (tipranavir) in hiv-infected patients.

Conditions: HIV Infections

Summary: this observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with aptivus (tipranavir) in combination with low-dose norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.


Eligibility criteria:
inclusion criteria: highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. aptivus (tipranavir), co-administered with low dose norvir (ritonavir), is indicated for combination antiretroviral treatment of hiv-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors. exclusion criteria: * age \< 18 years * pregnant female patients * hypersensitivity to the active substance or to any of the excipients. * patients with moderate or severe (child-pugh b or c) hepatic impairment. * rifampicin should not be used with aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect. * herbal preparations containing st john's wort must not be used while taking aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir. * co-administration of aptivus (tipranavir) with low dose norvir (ritonavir), with active substances that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. these active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and hmg-coa reductase inhibitors (simvastatin and lovastatin). in addition, co-administration of aptivus (tipranavir) with low dose norvir (ritonavir), with drugs that are highly dependent on cyp2d6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
the effects of ambulatory treatment at the dead sea on osteoarthritis of the knees

Conditions: Osteoarthritis of the Knees

Summary: this study will check the efficacy of balneological therapy of bathing in dead sea fountain waters over a 6 week period on a twice a week basis (overall 12 treatments) in patients suffering from osteoarthritis of the knees.

since stay in the dead sea for a long period of time is an expensive matter, it is important to determine whether twice a week treatments can be as beneficiary as two straight weeks of treatments as was shown to be effective in previous studies. our study will follow the patients for a longer period of time (6 months) than was done in previous studies. an additional advantage will be separating the therapeutical effect of our specific treatment from the therapeutical effect of being in a comfortable hotel away from the daily nuisances for 2 weeks which by itself has been shown to be pain relieving in patients suffering from rheumatic diseases. our study will take 50 patients suffering from osteoarthritis of the knees and divide them in to 2 equal groups. one group will be treated twice a week with thermo-mineral baths at the temperature of 35-36 degrees celsius for approximately 20 minutes. the other group will be treated twice a week with hot sweet water tub (without the water jets!) of the same temperature and for the same length of time. both groups will change nothing in their current medical treatment. the patients will be examined at 5 points during this study: a few days before their first treatment, right after their last treatment (after 6 weeks), after one month, after 3 months and after 6 months. all examination will be performed in the soroka university medical center. the clinical indexes and questionnaires which would be filled during this trial will be: 1. womac index 2. lequesne's index 3. visual analogue scale by the patient 4. visual analogue scale by the doctor 5. sf 36 and health assessment questionnaire (haq)

Eligibility criteria:
inclusion criteria: * patients suffering from osteoarthritis of the knees according to the conventional measurements of the american college of rheumatology and who are treated in the rheumatological clinics of the soroka university medical center exclusion criteria: * patients suffering from any other rheumatological disease other than osteoarthritis * patients that were previously treated with hydrotherapy or balneotherapy * patients suffering from balance disorders or loss of consciousness disorders such as epilepsy, arrhythmias etc.
melatonin and sleep spindles in autism

Conditions: Autism Spectrum Disorder

Summary: sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. we hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. this communication is mediated by the thalamic reticular nucleus (trn). due to its small size and location deep in the brain, we cannot assess trn function without invasive techniques. fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of trn function. in aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. in aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. if successful, this study will introduce trn as a target for treatment of sleep disruption and guide larger home-based sleep studies.


Eligibility criteria:
inclusion criteria: * male and female subjects with asd * 12-18 years of age * english speaking * able to understand and respond to questionnaires in english exclusion criteria: * pregnant or breastfeeding * substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary) * chronic medical conditions that affect sleep * any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease * history of head injury resulting in prolonged loss of consciousness or other neurological sequelae * iq \<70 * other neurological disorder, including seizure disorder * diagnosed sleep disorder * known genetic causes of asd * currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Keywords: melatonin